Advancing novel biologics through clinical trials
Make your innovation
our next project
The National Research Council of Canada's clinical trial material facility is uniquely positioned to help innovators advance novel biologics through clinical trials and bridge the gap between biomanufacturing research and commercial production.
This 1,700-square-metre facility is designed for developing biopharmaceuticals in compliance with good manufacturing practices (GMP) recognized by Health Canada, the United States Food and Drug Administration, and the European Medicines Agency.
The clinical trial material facility is operated by the Human Health Therapeutics Research Centre, which has established biomanufacturing expertise and one of the largest research and development teams in Canada dedicated to biologics development.
Virtual tour
Clinical trial material facility video: Transcript
[On screen: Clinical trial material facility]
Welcome to the National Research Council of Canada's clinical trial material facility.
We're uniquely positioned to help advance novel biologics through clinical trials in Canada and bridge the gap between biomanufacturing research and commercial production.
Our 1,700-square-metre facility is compliant with good manufacturing practices recognized in Canada, the United States and Europe.
It's operated by our knowledgeable team, with expertise in developing and scaling up robust biomanufacturing processes.
The clinical trial material facility is designed for biopharmaceuticals such as vaccines and therapeutics, and is ideally suited for producing clinical trial material, optimizing and verifying processes, technology transfer and early process validation.
In our sub-culture suite, we can optimize conditions for cell growth in successively larger vessels, up to 5 litres.
Optimal cell growth continues up to 500 litres in the upstream processing suite, where cell transfection or induction takes place.
Once the cell culture has produced the desired yield, the product of interest is transferred to our first downstream processing suite, where it's separated and purified, as needed, to generate the drug substance.
Depending on your needs, we can carry out additional concentration, pre-formulation and filtration in our second downstream processing suite before the bulk drug substance is packaged for shipping.
The NRC's clinical trial material facility. With state-of-the-art infrastructure and established biomanufacturing expertise, we're accelerating biologics development in Canada.
Let's make your innovation, our next project.
[On screen: official signature, National Research Council Canada / Conseil national de recherches Canada]
[On screen: Government of Canada Wordmark]
Targeted industries
Health and Biosciences, Biopharmaceuticals, Pharmaceuticals, Pharmaceutical Manufacturing, Personalized / Precision Medicine, Bioproducts
Capabilities
With its state-of-the-art public infrastructure and our established biomanufacturing expertise, the clinical trial material facility is ideally suited for production process optimization, technology transfer and small-scale biologics production.
Features
- Single-use production
- Containment levels 1 and 2
- Unidirectional design
- 50-litre and 500-litre bioreactors
- Vitus inactivation and nanofiltration train
- Pre- and post-virus purification train
- Tangential flow filtration (ultrafiltration)
- Cell amplification, production and clarification using depth filtration
- Chromatography skids for purification and polishing steps
- Bulk fill
- Process control capabilities
Types of production
- Fusion proteins
- Monoclonal antibodies
- Viral vectors
- Protein sub-units
- Virus-like particles
- Gene therapies
Services
The clinical trial material facility offers many possibilities for potential client use.
- Biologics production up to 500 litres (proteins, antibodies, vaccines, gene therapies)
- Technology transfer hub
- Optimization of GMP manufacturing processes
- GMP cell banks
Quality management system
Our quality management system provides overall guidance to ensure consistent and sustainable production of safe and effective products in compliance with GMP and applicable processes, policies, standards and regulations.
We integrate effective knowledge building, risk management and GMP requirements into all stages of our processes. Our system also provides a framework for knowledge transfer from clients to our teams in preparation for manufacturing clinical trial material.
Our value
With safe and reliable small-scale production capacity, the clinical trial material facility can help advance your novel biologic innovation through the final stages of R&D and with the production of material for phase I and phase II clinical trials.
Our processes are GMP-compliant and meet the standards of Canadian, American and European regulatory authorities.
Our experts are experienced, prepared and ready to help navigate the complex drug development pathway, starting at any stage of the process.
We can help increase the success and impact of your novel biologics project. Contact us to learn more.
Interested in working with the NRC's clinical trial material facility? Please complete our client intake form to help us better understand your project needs.
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Contact us
Minh-Luan Tran
Director, Clinical Trial Material Facility
Human Health Therapeutics Research Centre
Telephone: 438-832-6464
Email: minhluan.tran@nrc-cnrc.gc.ca
Paul Payette
Director, Business Development
Human Health Therapeutics Research Centre
Telephone: 613-204-8374
Email: paul.payette@nrc-cnrc.gc.ca
Media Relations
National Research Council of Canada
Email: NRC.MediaRelations-RelationsMedias.CNRC@nrc-cnrc.gc.ca